Drugs
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Duavee (conjugated estrogens/bazedoxifene acetate) is 5,683 days. Of this time, 5,317 days occurred during the testing phase and 366 days during the approval phase. Duavee is indicated for treating moderate to
Drugs
FDA has approved an Allergan supplemental NDA to expand the approved use of Avycaz (ceftazidime and avibactam) to include treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and
Drugs
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Lenvima (lenvatinib mesylate) is 3,580 days. Of this time, 3,396 days occurred during the testing phase and 184 days during the approval phase. Lenvima is indicated for treating patients with locally recurrent
Drugs
Four House committee leaders overseeing FDA 2/2 wrote commissioner Scott Gottlieb expressing concern over the risk of worsening U.S. shortages of heparin due to new supply pressures in China, currently the source of 60% of the crude ingredients used to manufacture heparin here. In an extensively researched 13-
Drugs
A 2/2 letter to FDA from 92 bipartisan members of the U.S. Senate and the House urges the agency to use all tools at its disposal to address the dire shortages of IV saline and other critical medical products caused by Hurricane Maria that devastated Puerto Rico’s
Drugs
Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA) have introduced the Over-the-Counter Drug Safety, Innovation, and Reform Act (S. 2315) in a bipartisan effort to overhaul regulation of over-the-counter (OTC) monograph drugs. Attorney Riette van Laack (Hyman, Phelps & McNamara) writes in her firm’
Drugs
FDA was one of 16 federal agencies that developed a “strategic roadmap” with a new framework for safety testing of drugs and chemicals that will provide more human-relevant toxicology data while reducing the use of animals. The National Toxicology Program published the roadmap 1/30. The agencies say the
Drugs
FDA has ordered a Boxed Warning on Intercept Pharmaceuticals’ liver disease drug Ocaliva (obeticholic acid) after determining that it is being incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury. The
Drugs
FDA has approved B. Braun Medical’s 0.9% sodium chloride injection, USP in the Ecoflac Plus 500 mL container. Over the past few years, B. Braun has worked with the agency to temporarily import Ecoflac Plus under regulatory discretion from an FDA inspected sterile injectable facility in Melsungen, Germany.
Drugs
The former head pharmacist at New England Compounding Center (NECC) has been sentenced to eight years of imprisonment for his role in the 2012 nationwide fungal meningitis outbreak that killed 64 and caused infections in 793 patients. Glenn Chin (Canton, MA) was also sentenced to two years of supervised release,
Drugs
The American Heart Association’s first scientific statement on the relationship between cardiovascular disease (CVD) and breast cancer says that with the evolving intersection of the cardiovascular and oncologic fields, “comprehensive care is an essential element in the management of cancer patients to maximize gains in cancer treatment while minimizing
Drugs
President Donald Trump again has urged Congress to pass “right-to-try” legislation to allow patients with terminal conditions to have access to unapproved experimental treatments. Speaking at a 2/1 Republican retreat in West Virginia, Trump echoed remarks he made during his State of the Union address 1/30
Drugs
FDA commissioner Scott Gottlieb says FDA is working closely with companies that manufacture saline to limit and improve the shortage issues, using all of its tools and resources. In an update, Gottlieb says the agency expects supplies of saline to increase over the next month. He notes that having adequate
Drugs
FDA has accepted for priority review an Alnylam Pharmaceuticals NDA for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for treating hereditary ATTR (hATTR) amyloidosis. The inherited, progressively debilitating, and often fatal disease is caused by mutations in the TTR gene. TTR protein is produced primarily in the liver and
Drugs
A 6/2017 conference convened by the Yale Collaboration for Research Integrity and Transparency that brought together concerned academics, patient advocates, legal and medical experts, and leaders from international organizations to talk about serious problems and dysfunctions in how medicines are developed, tested, reviewed, marketed and used, developed seven points
Drugs
FDA has placed a clinical hold on Bellicum Pharmaceuticals’ U.S. studies of its BPX-501 after reports of three cases of encephalopathy possibly related to the drug. The company says it is awaiting formal FDA communication on the requirements for resuming studies, and will work closely with the agency
Drugs
President Donald Trump acknowledged FDA and its record approvals last year in his 1/30 State of the Union address. “To speed access to breakthrough cures and affordable generic drugs, last year the FDA approved more new and generic drugs and medical devices than ever before in our history,” he
Drugs
Alkermes has filed an NDA for ALKS 5461 (buprenorphine and samidorphan), a once-daily, oral investigational drug for the adjunctive treatment of major depressive disorder (MDD). The submission is based on data from more than 30 clinical trials and more than 1,500 patients with MDD. Buprenorphine is a partial
Drugs
FDA has granted Aquestive Therapeutics an orphan drug designation for riluzole oral soluble film (OSF) for treating amyotrophic lateral sclerosis (ALS), which affects about 30,000 Americans. Riluzole OSF is currently in late-stage clinical development. Patients suffering from ALS often have difficulty swallowing. Riluzole film was developed to dissolve
Drugs
FDA has approved a Ferring Pharmaceuticals supplemental NDA for Zomacton (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH), indicated for hormone replacement in adults with GH deficiency. The drug was previously approved for treating pediatric patients who have growth failure due to an inadequate secretion
Drugs
A Massachusetts federal judge sentenced Aegerion Pharmaceuticals for improperly marketing its Juxtapid cholesterol drug and ordered that some of the $40.1 million it agreed to pay as part of a plea bargain be divided among some of the company’s victims. A Reuters report says that prosecutors had charged
Drugs
A 7/18-7/21/17 FDA inspection at Daito Kasei Kogyo, Okayama, Japan, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API), according to a 1/18 Warning Letter. Specific deviations were: * failing to ensure that appropriate laboratory tests are conducted for each batch